In Cambodia, malaria cases and related deaths have steadily decreased from a peak in 1999. However, the threat of Plasmodium falciparum resistance to artemisinin medicines has limited the country’s efforts to contain malaria. A national pharmacovigilance (PV) system was established in 2008 with the creation of the Cambodian PV Center and a revision of the National Medicine Policy to include medicine safety statements.
USAID and the Food and Drug Administration funded SIAPS to assess PV systems’ performance in selected Asian countries in 2013. Objectives of the assessment included benchmarking national systems’ performance, identifying replicable and successful experiences, mapping the contributions of donor agencies, and recommending options for enhancing PV and post-market surveillance systems. In 2015, the US President’s Malaria Initiative, with funding from the USAID Regional Development Mission for Asia and the USAID Mission in Cambodia, supported SIAPS to conduct a study of efforts to combat the availability of substandard and counterfeit medicines in the Greater Mekong Subregion.
The assessment of the PV system in Cambodia used the indicator-based pharmacovigilance assessment tool (IPAT) developed by the USAID-funded Strengthening Pharmaceutical Systems Program, a predecessor to SIAPS, while the second study reviewed literature and interviewed stakeholders.
- Cambodia evolved from Book I (Drug Regulations) in 1994 to Book III in 2012. The country has procedures in place and a drug review committee responsible for registration. At the time of the assessment, 10,355 pharmaceutical products were registered at the Department of Drugs and Food Cambodia, including 24 antimalarial medicines. Quality assurance inspection teams were established at the central and provincial levels. Stocking of oAMTs decreased from 20% (2009) to 4.2% (2011) in private-sector outlets that stock antimalarials. There was a ban on artemisinin monotherapy in 2011, and the availability of oAMTs decreased to 0.2% in the public nonprofit sector and 1.6% in the private sector. The prevalence of counterfeit and substandard medicines in Cambodia has decreased gradually each year according to testing conducted by the USP/PQM program. The assessment found that countries have approved national ADR forms, but their availability at health facilities is limited.
- Core PV topics were incorporated in the preservice training curricula, and health care workers have been trained on PV and medicine safety.
- National PV guidelines were up to date.
- A local electronic database system was used to collect PV data from all sources using standard dictionaries and terminologies to transcribe reported events (i.e., WHO-ART, MedDRA).
- Drug and therapeutics committees addressed medicine safety issues.
Interventions that Decrease the Prevalence of Counterfeit Medicines on the Market
- Prepackaged medicines (a combination of mefloquine and artesunate) improve the quality of first-line antimalarial medicines. As a result, only WHO-prequalified products were procured with donor funding for the public and private sectors.
- The US Centers for Disease Control and Prevention provided technical support to the Mekong Malaria Partnership (a partnership among Mekong countries, WHO, USAID, and other partners) for malaria control.
- The interministerial committee was established through the national malaria control program in 2005 and took action to combat counterfeit medicines.
- Population Services International/Cambodia subsidized ACTs and RDTs for the private sector to improve public health with funding from the Global Fund and the Bill and Melinda Gates Foundation.
- The Prime Minister launched the National Elimination Strategy 2011–2025, and malaria-related news and stories have been shared widely.
Gaps in Addressing the Quality of Antimalarial Medicines
- Limited human resource capacity for monitoring the quality of medicines and performing the responsibilities that should be covered under the national regulatory authority (NRA)
- GMP compliance of local pharmaceutical manufacturers needs improvement
- Limited PV activities
- Limited sharing of information on identified counterfeit medicines with health care professionals and the public
- Limited funding for an interministerial committee at the central and provincial levels
- Limited capacity of the police to identify, seize, and remove counterfeit and substandard medicines from the market
- Pharmacovigilance activities have started but are not yet fully functioning
- Limited access to quality ACTs in border and remote areas because of poor transportation to public health care facilities and a lack of legitimate drug sellers
- Lack of affordability, which leads the poor to seek cheaper medicines
Options for the Way Forward
- Enhance the capacity of the NRA through technical assistance
- Through close cross-border collaboration in the Greater Mekong area, health ministries of participating countries can exchange information in a more effective way to contain the spread of counterfeit medicines in border regions
- Adverse events reporting can be improved by designating regional PV centers, particularly in university hospitals where there is access to qualified physicians, pharmacists, and nurses
- Develop an online database for managing reports
- More specific information about the indicators included in IPAT can be found here.
- Comparative Analysis of Pharmacovigilance Systems in Five Asian Countries
- Analysis of the Regulatory Capacity to Assure the Quality of Antimalarial Medicines in Selected Countries of the Greater Mekong Subregion of Asia